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THE USE OF unlicensed springs in surgeries at Temple Street Children’s Hospital in Dublin “was wrong”, according to a review carried out by the Health Information and Quality Authority.
According to Hiqa, its review team believes that the use of the non-CE-marked springs formed part of “a well-intentioned but ill-considered effort to provide an alternative approach to surgical treatment, involving a single operation, for a number of children with life-limiting conditions” who had otherwise been facing multiple operations, each with its associated risks.
Hiqa also found that governance changes within Children’s Health Ireland (CHI) meant that a number of policies and safety checks “were not properly applied” in treating the children affected, “resulting in the springs being used inappropriately”.
The review makes 19 recommendations, including an organisation-wide review of corporate and clinical governance at CHI “to ensure clarity and effective assurance of safe, quality care”. It can be read on Hiqa’s website.
The statutory review was commissioned in 2023 after it emerged that non-CE-marked metal springs had been surgically implanted into a number of children who underwent spinal surgery at CHI at Temple Street.
The consultant at the centre of the review was referred to the Irish Medical Council after two serious incidents in children undergoing spinal surgery, including the death of a child.
The HSE also commissioned an external review into CHI’s spinal surgery services, led by Liverpool-based consultant orthopaedic surgeon Selvadurai Nayagam. It is not clear when this review will be completed.
The Hiqa review covers the period from November 2018, when the use of the springs was first considered as a possible treatment option for a number of children attending Temple Street, to July 2023, when it was confirmed internally by CHI that the springs implanted into a number of children during spinal surgery, between 2020 and 2022, were not CE marked.
The review states that the springs were used as an addition to a “well-established and completely separate conventional growing-rod system” in use in the hospital for treating irregular curvatures of the spine.
It found that the surgeon who conducted the surgical procedures using the springs, known in the report as Surgeon A, attended an expert international orthopaedic conference on early onset scoliosis in 2018.
At the conference, a team of researchers from The Netherlands presented the initial findings of a new implantable ‘spring-distraction system’ for the treatment of scoliosis.
Medical-grade titanium springs, manufactured by the university, were used in this study. “The research team from The Netherlands told Hiqa that they were not contacted by Surgeon A at any time to discuss their research,” the report states.
It found that Surgeon A engaged with the then-Principal Clinical Engineering
Technician at Temple Street to purchase the springs, but that there was an absence of structures and processes “to support clear and adequate communication” between them on the intended purpose of the springs.
Hiqa found no evidence of written records to demonstrate appropriate detailed discussions with parents to secure their consent for the use of the springs in line with the National Consent Policy 2013.
“Furthermore, Hiqa found no evidence of any description of any written information provided to the parents to read, regarding the use of the springs and the new nature of the intended surgery in seeking to replicate the spring distraction system,” it states.
The review states that Surgeon A told Hiqa that in their view, the use of the springs “was not for innovation or research purposes”.
Hiqa found that the use of the unauthorised springs was an attempt “to replicate a new technique – which was being used as part of a scientific study for which outcomes had yet to be published in a peer reviewed scientific journal – but in a modified way”.
It found the springs implanted in children were made of a material called non-alloyed spring steel, which is not used for surgical implantation.
It also found that level of documentation and information provided to the families “was wholly inadequate to describe the exact nature of the intended procedures”.
“The use of the springs in this manner should not have happened,” Hiqa states.
According to Hiqa, while there were some arrangements in place at local hospital site level, relevant structures and processes for the safe introduction and use of medical devices were not in place.
There were no overarching CHI-wide standardised governance structures and supporting policies and procedures in place for the introduction and use of medical devices.
There was also a lack of formal documented procedures to be followed within CHI for the introduction and use of a non-CE marked medical device in any of the specific circumstances where one of these devices could be used.
At Temple Street, there were no formal multidisciplinary processes for assessing and approving implantable medical devices. As a consequence, the approval process, where followed, fell to the relevant clinical director.
“This was inadequate to ensure effective oversight,” Hiqa states.
There was also no formal mechanism for CHI senior management oversight of the management of health technology and medical devices, and there was no committee in place to approve and oversee the introduction of implantable medical devices.
The review also found that up to November 2023, Temple Street and Crumlin Hospital did not have a standardised set of policies and procedures for theatres.
The review goes on to state that the controls in place within CHI for the management of end-to-end processes “did not provide the necessary adequate safeguards at each stage of the process”, including those needed for “the procurement, introduction and decontamination and use of the springs in surgeries”.
There were also “underlying challenges” that may have undermined effective team working and the promotion of a culture of questioning within and across teams, Hiqa states.
Due to failures in the design and delivery and oversight of end-to-end processes and controls within the spinal service at CHI, children were not protected from the risk of harm.
The overall governance structures and management arrangements at CHI were found to be “overly complex” and did not enable effective management and oversight of the orthopaedic service at CHI Temple Street.
The review states that between November 2018 and July 2023, CHI was experiencing “significant organisational and transformational change”.
After CHI was established as a legal entity in 2019, changes to organisational structures were made. These included hospital site-specific CEO positions at Temple Street and Crumlin being stood down, with the clinical directors for the sites assuming management responsibility.
A single clinical director was also appointed as an executive lead at both CHI at Tallaght and CHI at Connolly. These clinical directors were later appointed to lead three new clinical directorates across all hospital sites in 2021.
The review states that these arrangements were overly complex and placed “an onerous and unrealistic workload expectation on the clinical directors and senior managers operating within this structure”.
It states that the changes led to “unclear lines of reporting and accountability across the wider organisation” which did not allow for “effective oversight and assurances” by the CHI board, which could not ensure the safe introduction and use of new surgical implants and implantable medical devices.
Hiqa states that as a consequence of this, a number of key approval processes, policies or safety checks “were not properly applied in treating these children, resulting in the springs being used inappropriately”.
Hiqa’s director of healthcare regulation Sean Egan said: “It is essential that
key lessons are learned from this review at both CHI, and in other health services
nationally, particularly with respect to the governance of clinical innovation and
practice.”
In a statement this afternoon, Children’s Health Ireland acknowledged the publication of the report and apologised to the families affected by the use of unauthorised springs.
CHI CEO Lucy Nugent said: “Children’s Health Ireland is an organisation that exists with a singular focus to deliver safe, quality care to children and young people. We are deeply sorry that these children, young people and families did not get the care they deserved. This is unacceptable.
Children’s Health Ireland sincerely regrets and apologises for the risks that were posed to three patients through the use of non-CE-marked spring implants in their spinal surgeries.
“We do not underestimate the impact that this has had and is having on the families affected, and the distress that it has caused to all patients and families in the spinal service.”
Nugent said the findings and recommendations from Hiqa will be implemented through a quality improvement plan, adding that CHI is committed to ensuring “robust governance and compliance processes and to providing safe, high-quality, and child-centred healthcare services”.
“Issues of poor performance and non-compliance with policies are being addressed with the staff involved, in line with relevant hospital policies. I want to assure families of my commitment to ensuring that something like this never happens again in our organisation.”
Children’s Health Ireland said it “entirely accepts” Hiqa’s findings and recommendations, adding that five of the recommendations have been completed with the remainder partially completed.
The HSE said it also accepts the report’s findings. It said the recommendations will be “immediately followed through to implementation”, adding that it will also be seeking oversight of how CHI approaches the recommendations specific to them.
“What happened here was wrong and unacceptable,” HSE CEO Bernard Gloster said.
“Given the role of the HSE in funding CHI I want to offer a sincere and unequivocal apology to the children and families affected by these issues.
“I will be requesting an early meeting with the Board and Executive of CHI to set out our clear expectations in all matters of governance and oversight.”
Minister for Health Jennifer Carroll MacNeill thanked Hiqa for conducting the review and the families who contributed to it.
“As patients and parents, we put our trust in healthcare professionals. That is particularly the case here where parents had put their trust in clinicians to treat their very sick children,” she said.
This HIQA report is clear that their trust was breached in this case. These children were not protected from the risk of harm, as they should have been.
The Health Minister said she met with the CEO and chairperson of CHI yesterday. “I made very clear to them my deep disquiet at what happened here and my clear expectations in terms of reform and change to ensure it does not happen again.
“I note that both CHI and the HSE have accepted the recommendations of this review in their entirety and have already begun to implement them. I also note that they have apologised in full to the patients and families for the failings outlined in this report.”
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